Catalog Number

-

Brand Name

Sapphire External Battery Pack

Version/Model Number

15079-111-0001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K192860,K192860,K192860

Product Code

MRZ

Product Code Name

Accessories, Pump, Infusion

Public Device Record Key

2430f66a-b187-4bf8-9b77-13c53d67fab1

Public Version Date

May 23, 2022

Public Version Number

1

DI Record Publish Date

May 15, 2022

Package DI Number

27290109153999

Quantity per Package

10

Contains DI Package

17290109153992

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard box